Compositions and methods for preparation of poorly water soluble drugs with increased stability

Abstract

The present invention provides stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions. The use of stabilizing agents provide extended stability of nanoparticle suspensions and other formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration.

1 - 36 . (canceled) 
     
     
         37 . A stable docetaxel pharmaceutical injectable composition comprising
 a) docetaxel;   b) polysorbate 80; and   c) a stabilizing agent, wherein the stabilizing agent is citric acid.   
     
     
         38 . The stable docetaxel pharmaceutical injectable composition of  claim 37 , wherein the composition is sterile. 
     
     
         39 . The stable docetaxel pharmaceutical injectable composition of  claim 37 , wherein the composition is chemically stable upon prolonged storage. 
     
     
         40 . The stable docetaxel pharmaceutical injectable composition of  claim 37 , wherein the composition is stable for at least about 72 hours. 
     
     
         41 . The stable docetaxel pharmaceutical injectable composition of  claim 37 , wherein the concentration of docetaxel is about 30 mg/ml to about 40 mg/ml. 
     
     
         42 . A method of preparing the docetaxel pharmaceutical injectable composition of  claim 37  comprising combining the stabilizing agent, docetaxel, and polysorbate 80. 
     
     
         43 . The method of  claim 42 , wherein the method comprises adding the stabilizing agent to a composition comprising docetaxel and polysorbate 80.